| Date Initiated by Firm | March 27, 2019 |
|---|
| Create Date | May 17, 2019 |
|---|
| Recall Status1 |
Terminated 3 on May 01, 2020 |
| Recall Number | Z-1367-2019 |
|---|
| Recall Event ID |
82663 |
| 510(K)Number | K990847 |
|---|
| Product Classification |
Microtools, assisted reproduction (pipettes) - Product Code MQH
|
| Product | ICSI MICROPIPETTE
CooperSurgical part number: MICC001-30-B1.0 |
|---|
| Code Information |
Lot 1557 |
| FEI Number |
1216677
|
Recalling Firm/
Manufacturer |
CooperSurgical, Inc.
95 Corporate Dr
Trumbull CT 06611-1350
|
Manufacturer Reason
for Recall | ICSI CUSTOM MICROPIPETTES the thirty-degree bend is absent |
|---|
FDA Determined
Cause 2 | Under Investigation by firm |
|---|
| Action | CooperSurgical issued recall letter dated March 27, 2019 identified problem and action to take: discontinue use of this discrepant product, quarantine the product, and complete the Acknowledgement and Receipt Form to arrange for either a product replacement or credit to your account through CooperSurgical.
Contact: 203-601-5200 ext. 3300. |
|---|
| Quantity in Commerce | 480 units |
|---|
| Distribution | Foreign: Denmark, Italy, Sweden |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = MQH
|
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